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Clinical trial

Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes: Assessment of Vaccine Selection and Outcomes for the Follow-on Study Year

ID
Name
INSI-201805
Description
The purpose of this study is to determine if different influenza vaccines produce different outcomes in nursing facility residents receiving the required annual influenza vaccination.
Trial arms
Trial start
2018-07-13
Estimated PCD
2019-02-15
Trial end
2023-01-25
Status
Completed
Treatment
Influenza
Facilities will be asked to complete a survey to evaluate the impact of the influenza vaccine choice on hospitalization risk for the 2017-2018 influenza season.
Arms:
Follow-On Cohort, Parallel Cohort
Size
598
Primary endpoint
Hospitalization for all causes
up to 1 year
Eligibility criteria
Inclusion Criteria: * Participated in the Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes study * OR * Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites Exclusion Criteria: * Facilities having fewer than 50 long-stay residents * Hospital based facilities * Facilities with more than 20% of the population under age 65 * Facilities not submitting Minimum Data Set (MDS) data
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 598, 'type': 'ACTUAL'}}
Updated at
2023-03-16

1 organization

1 product

3 indications

Organization
Insight Therapeutics
Product
Influenza
Indication
Influenza
Indication
Influenza-like illness
Indication
Human